The Recall Desk
HighFDA (Devices)·Z-2727-2026·Announced 2026-07-22

GE Optima XR200/220/240amx Radiographic System Column Safety Mechanism

GE Medical Systems is recalling certain Optima XR200/220/240amx mobile radiographic systems after column replacements because functional testing of the safety pawl may not have been performed, which could allow the X-ray arm to drop and injure patients.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall involving a risk-of-harm medical device (potential patient injury from a falling X-ray arm assembly). The source text does not report any known illnesses or injuries; the hazard is theoretical based on the identified safety mechanism failure. Per the rubric, Class II with risk-of-harm but no reported injury supports a score of 3.

Plain-English summary

GE HealthCare is recalling certain Optima XR200/220/240amx mobile digital-ready radiographic systems that have undergone column replacement. In these systems, functional testing of the safety pawl may not have been completed to verify proper assembly.

If the internal counterpoise cable fails, the Column Safety mechanism will not function properly. This could cause the arm carrying the X-ray tube and collimator to drop downward along the column track, potentially resulting in patient injury during an examination.

The recall affects 38 units distributed worldwide, including the United States and Brazil, Canada, Korea, Mexico, Saudi Arabia, Spain, and the United Kingdom. Facilities currently using affected systems should contact GE Medical Systems for guidance on remediation and safety measures.

The recalled product

Product
Optima XR220amx, Mobile Digital-Ready Radiographic System
Manufacturer
GE Medical Systems, LLC
Category
Medical Device — Radiographic System
Hazard
Affected units
38

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • UDI-DI: 00840682115261
  • System IDs: 05249MOB02.OLD
  • 205820DP1
  • 228818XR220
  • 229276M1
  • 240566P1
  • 301295OPTIMA2
  • 303788SBOPT1
  • 314251P5
  • 352LEEDP1
  • 386FLGDPXR3
  • 417347DPORT1
  • 512SAMCSB
  • 516632OPTIMA2
  • 540981ODP7
  • 563264OPT
  • 601445DP1
  • 615338HDP01
  • 661949DP2
  • 713441OPCDX1

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by GE Medical Systems, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · GE Medical Systems, LLC

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Same hazard · equipment failure

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